Phenogen Sciences, Inc., a US subsidiary of Australia-based Genetic Technologies Limited, was established in 2010 as a global expansion strategy of the company’s oncology and cancer management diagnostics business. As a pioneer in personalized healthcare,Phenogen Sciences offers novel predictive testing and risk assessment tools that help physicians proactively manage the health of their patients. Phenogen’s lead product, BREVAGenplus® is the first clinically validated predictive risk test that combines genetic and clinical data to categorize a woman’s personal risk of developing breast cancer.
Its Parent Company, Genetic Technologies Limited , founded in 1989, is an established Australian-based global genetic testing business specializing in cancer diagnostic, with a focus on Risk Assessment Products. Listed on the ASX (GTG) in 2000 and NASDAQ (GENE) in 2005, the Company has established a successful fee-for-service genetic testing business that is primarily focused on the U.S. market.
From its headquarters in Melbourne, Victoria, the Company’s laboratory holds a number of accreditations including:
- The Clinical Laboratory Improvement Amendments (CLIA) license required for all laboratories offering test in the U.S.;
- The Clinical Laboratory Evaluation Program (CLEP) license, an additional certification required to offer test in New York State;
- A Medical Device Establishment License (MDEL) required for Canada;
- The BREVAGenplus test CE marked for sale in Europe; and
- The laboratory complies with the International Organization for Standardization (ISO), enabling it to accept test samples from anywhere in the world.
- BREVAGenplus provides information about breast cancer risk over a 5 year period; it does not diagnose breast cancer
- BREVAGenplus is validated in African American, Caucasian, and Hispanic women age 35 years or older
- The risk estimate used in this test does not take into account several other breast cancer risk factors, such as an extensive family history of breast and ovarian cancer and thus does not provide a lifetime risk score
- This test is used for clinical purposes
* BREVAGenplus is not applicable to women who are already at high risk of breast cancer including those that have a personal or extensive family history of breast and/or ovarian cancer, LCIS, DCIS, AH or have thoracic RT under 30y. Any women with these risk factors are already at increased risk of breast cancer and should be screened and followed as such.